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Researchers launch major study to unravel mysteries of excess male hormones

NCT ID NCT00250159

Knowledge-focused Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 09, 2026 · Updated 20 times

Summary

This natural history study aims to gather information from up to 3,000 people with genetic conditions that cause too much androgen (male-like hormones), such as congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). Participants undergo various tests including blood work, glucose tolerance tests, imaging, and cognitive assessments to better understand how excess androgen affects growth, fertility, mood, and overall health. The study does not test any new treatment but will help doctors learn more about these conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2006

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with excess androgen, CAH, FMPP as well as their parents.

Ages

1 day to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 1. Males, ages 0 - 99 with known or suspected FMPP or 2. Patients (males and females, ages 0 - 99) with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type. 3. Patients with excess androgen of unknown etiology or 4. Relatives of patients in this protocol. EXCLUSION CRITERIA: 1. Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no longer be followed on this protocol. 2. Patients with significant non-endocrine medical conditions. 3. Females who are pregnant at the time of initial enrollment.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency congenital adrenal hyperplasia due to 3-beta-hydroxysteroid dehydrogenase deficiency familial male-limited precocious puberty Familial Testotoxicosis precocious puberty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia (CAH) Familial male-limited precocious puberty (FMPP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medstar Washington Hospital Center

    COMPLETED

    Washington D.C., District of Columbia, 20010, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.